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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04491487
Other study ID # 3347
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date April 1, 2021

Study information

Verified date February 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP) counselling on patients undergoing total laryngectomy in terms of levels of distress, post-traumatic stress symptoms, anxious-depressive symptoms, acquisition and acceptance of the new voice. This is a randomized controlled trial (RCT) of patients undergoing total laryngectomy and primary tracheoesophageal puncture. Patients will be randomized into two groups: an Experimental group that will receive a pre-operative SLP counselling session and a Control group that will not receive it. The investigators will administer a structured interview and three questionnaires: the Impact of Event Scale - Revised (IES-R), the Psychological Distress Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS). The data will be collected between the 5th and 7th day after surgery (T0), 1-month (T1) and 3-months (T2) after being discharged from hospital.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date April 1, 2021
Est. primary completion date February 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age 18 years and over; - patients waiting for TL and primary TEP; - patients able and willing to provide written informed consent. Exclusion Criteria: - positive history for psychiatric or psychological disorders, - neurological disorders, - ineligibility for voice prosthesis rehabilitation.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
pre-operative counselling
pre-operative Speech-Language Pathology (SLP) counselling before Total Laryngectomy

Locations

Country Name City State
Italy Fondazione Policlinico Universitario A.Gemelli IRCCS Roma

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impact of Event Scale-revised presence of post-traumatic symptoms Between the fifth and seventh post-operative day (T0)
Primary Impact of Event Scale-revised presence of post-traumatic symptoms one month after being discharged from hospital (T1)
Primary Impact of Event Scale-revised presence of post-traumatic symptoms three months after being discharged from hospital (T2)
Secondary Psychological Distress Inventory psychological distress levels Between the fifth and seventh post-operative day (T0)
Secondary Psychological Distress Inventory psychological distress levels one month after being discharged from hospital (T1)
Secondary Psychological Distress Inventory psychological distress levels three months after being discharged from hospital (T2)
Secondary Hospital Anxiety and Depression Scale anxiety and depression levels Between the fifth and seventh post-operative day (T0)
Secondary Hospital Anxiety and Depression Scale anxiety and depression levels one month after being discharged from hospital (T1)
Secondary Hospital Anxiety and Depression Scale anxiety and depression levels three months after being discharged from hospital (T2)
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